Plaque inhibiting composition and method

ABSTRACT

This invention discloses compositions effective in inhibiting or reducing plaque in the oral cavity. Chewing gums are a preferred vehicle for delivering the plaque inhibiting benefit of the present invention.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the practice of dental hygiene, and inparticular, to the removal of, or the inhibition of the growth of plaquein the oral cavity.

2. Description of the Art

The following references, while not exhaustive discuss various materialswhich are included in compositions which contact the oral cavity.Salzmann, in U.S. Pat. No. 2,744,049 issued May 1, 1956, discussesdental creams containing a partial ester of glycerine and a higher fattyacid material. The Salzmann patent also discusses the use of dicalciumphosphate dihydrate as an abrasive, and as well the use of sodium laurylsulfate. U.S. Pat. No. 3,622,662 issued to Roberts et al, Nov. 23, 1971,describes dental creams which may contain various zinc salts or sodiumlauryl sulfate and compositions which may be flavored with peppermint,spearmint or clove oils.

Clark, in U.S. Pat. No. 3,930,026 issued Dec. 30, 1975, describes theenhancement of flavor in chewing gums obtained by sorbing the flavoringonto a hydrophilic colloid in conjunction with a surfactant. Among thesurfactants disclosed are anionic materials, including sodiumdi(2-ethylhexyl)sulfosuccinate. Clark also states that nonionicsurfactants may be used to sorb the flavor into the gum including fattyacid monoglycerides or fatty acid diglycerides. British Pat. No.1,290,627 in the name of Pader, published Sept. 27, 1972, describesmouthwashes, having activity against calculus and plaque, containingzinc salts and further describing the use of sodium lauryl sulfate toprovide foaming action.

British Pat. No. 1,296,952 reported by Cancro et al and publishedNov.22, 1972, states that plaque and calculus may be diminished by zincphenolsulphonate and certain enzymes in dentifrice compositions. TheCancro patent also describes the use of certain abrasives, bufferingagents, and various surfactants. British Pat. No. 1,372,932 publishedNov. 6, 1974, describes purported anticaries compositions includingchewing gums, dentifrices and candylike products. In particular, theaforementioned British patent states that stearoyl-2-lactylate has beenfound effective to inhibit the production of dextran in the mouth.

Canadian Pat. No. 959,764 issued Dec. 24, 1974, to Pader, describesdentifrice compositions containing a source of zinc ions and variousenzymes. Pader also describes various surfactants which may be includedin toothpastes, including sodium lauryl sulfate and dioctyl sodiumsulfosuccinate.

U.S. Pat. No. 4,022,880 issued to Vinson et al, on May 10, 1977,describes compositions for inhibiting dental plaque containing a sourceof zinc ions and a halosalicylanilide, a quaternary ammonium compoundand other specified materials. The Vinson et al patent also states thatsodium lauryl sulfate and polishing agents may be used in thecompositions. Hass in Ser. No. 124,465, filed Mar. 15, 1971 disclosesthat stearoyl-2-lactylate may be used to prevent the formation ofdextran in the mouth.

Yolles, in U.S. Pat. No. 3,818,107 issued June 18, 1974, describeschewing gums which incorporate the flavor in a polymeric backbone.Yolles states that the flavor release in the chewing gum is sustained bythe molecular arrangement of the flavor group. In U.S. Pat. No.3,651,206 issued to Litchfield et al on Mar. 21, 1972, are describedchewing gums containing various aliphatic aldehydes as anticariesagents. Various oral preparations for preventing dental plaque aredescribed in U.S. Pat. No. 3,940,476 issued Feb. 24, 1976 to Hass.Comollo states in U.S. Pat. No. 3,984,574 issued Oct. 5, 1976 thatnon-tacky chewing gums may be made containing mono- and diglycerides offatty acids in an amount up to ten percent (10%) by weight of the basecomposition.

U.S. Pat. No. 3,821,417 issued to Westall et al on June 28, 1974,describes the use of dihydrochalcone in chewing gums. This patentfurther describes the use of butylated hydroxyanisole, butylatedhydroxytoluene and propyl gallate as antioxidants in chewing gums.DuRoss, in U.S. Pat. No. 3,973,041 issued Aug. 3, 1976 describes the useof sorbitol powder, butylated hydroxyanisole, and glycerine in chewinggums. Additional disclosures of sorbitol as well as other sugars, suchas xylitol, are made in various United States Patents including: U.S.Pat. No. 4,000,320 issued to Klose et al on Dec. 28, 1976; U.S. Pat. No.3,899,593 issued to Hammond et al on Aug. 12, 1975, U.S. Pat. No.3,914,434 issued Oct. 21, 1975 to Bohni; U.S. Pat. No. 3,296,079 issuedJan. 3, 1967 to Griffin; and U.S. Pat. No. 3,655,866 issued Apr. 11,1972 to Billoti.

Dental plaque is a deposit which accumulates on the teeth and adjacentsurfaces in the oral cavity. The plaque is a product of microbialgrowth, primarily derived from food residues in the mouth. Mucoproteinsand minerals present from the saliva and dead cells in the mouth alsoassist in plaque formation.

Plaque is removed to some extent by effective brushing of the teeth, butthe less accessible and more sheltered areas of the mouth which cannotbe readily reached by a toothbrush, are particularly susceptible toplaque and eventually, calculus growth. Left unhindered, the plaqueincreases in size and more tenaciously adheres to the teeth. Thebacterial metabolism within the plaque on the tooth surface results inthe production of acids, toxins and enzymes which are deleterious to theneighboring oral tissues. It has been stated that there is evidencepointing to plaque as being the direct cause of dental caries, due tothe generation of acids within the plaque structure. In any event plaqueis unsightly, and undesirable.

The present invention describes ingredients in compositions to retardand/or remove plaque from the surface of the teeth. It is also notedthat when the plaque is removed or prevented from forming upon theteeth, that the potential growth of calculus is also advantageouslylimited.

The embodiments of the plaque inhibiting composition are described belowin the summary of the invention.

Throughout the specification and claims, percentages and ratios are byweight, and temperatures are in degrees Celsius, unless otherwiseindicated.

SUMMARY OF THE INVENTION

The present invention encompasses a composition for use in the oralcavity to moderate the incidence of dental plaque comprising:

(a) from about 0.001% to about 15% by weight of an alkyl sulfate salt;

(b) from about 0.001% to about 15% by weight of adi(2-ethylhexyl)sulfosuccinate salt,

(c) from about 0.0005% to about 10% by weight of butylatedhydroxyanisole;

(d) from about 0.001% to about 5% by weight of a zinc compound; and,

(e) from about 0.05% to about 10% by weight of a plaque inhibitingflavor selected from the group consisting of cinnamon oil, peppermintoil, and spearmint oil and mixtures thereof.

The present invention in a solid form food product containing:

(a) from about 0.001% to about 15% by weight of an alkyl sulfate salt;and,

(b) from about 0.001% to about 15% by weight of adi(2-ethylhexyl)sulfosuccinate salt,

(c) from about 0.0005% to about 10% by weight of a butylatedhydroxyanisole;

(d) from about 0.001% to about 5% by weight of a zinc compound; and,

(e) from about 0.05% to about 10% by weight of a plaque inhibitingflavor selected from the group consisting of cinnamon oil, peppermintoil, and spearmint oil and mixtures thereof.

The present invention in a chewing gum containing:

(a) from about 0.001% to about 15% by weight of an alkyl sulfate salt;

(b) from about 0.001% to about 15% by weight of adi(2-ethylhexyl)sulfosuccinate salt,

(c) from about 0.0005% to about 10% by weight of butylatedhydroxyanisole;

(d) from about 0.001% to about 5% by weight of a zinc compound; and

(e) from about 0.05% to about 10% by weight of a plaque inhibitingflavor selected from the group consisting of cinnamon oil, peppermintoil, and spearmint oil and mixtures thereof; and,

(f) from about 10% to about 95% by weight of a gum base.

DETAILED DESCRIPTION OF THE INVENTION

As shown in the summary of the invention, the plaque inhibitingcompositions of the present invention may take several forms. That is,the present invention is concerned with the application of thecompositions described herein to the oral cavity and are not limited toany particular vehicle, although certain preferred forms of thecomposition are enumerated.

Broadly stated, the present invention embraces mouthwashes, toothpastes,toothpowders and other dental applications such as painting of thecomposition onto the tooth surface. In the food product line, thepresent invention envisages all forms of liquid and dry foods, includingsoft drinks, cocoa powders, and dairy products such as milk supplementedwith the compositions of the present invention. Snack foods such aspotato chips, cheese curls, candies in both hard and soft form includingchocolates, mints, troches, lozenges, chewable stick candy and the likeare also utilized. Of particular interest in the present invention areall forms of chewing gum which provide an excellent delivery system forthe compositions of the present invention.

Chewing gums include those with natural and synthetic bases as describedbelow and are also inclusive of bubble gum. Chewing gum is a preferredvehicle for delivering the compositions of the present inventionbecause, due to the inherent nature of chewing gum, a prolonged periodof contact with the oral cavity is reached. Moveover, the gum base canprovide for sustained release of the active components of the presentinvention, thus minimizing the amount of the active components whichmust be used.

As used in the present invention the term effective amount of thecomposition is used synonymously with the term sufficient amount, bothterms referring to the amount of the composition required to achieveplaque reduction or inhibition. There is no set definition for theamount of the composition required to achieve the desired plaqueinhibition. That is, the in use concentration of the various componentsof the composition will depend upon the manner of application to theoral cavity. Specifically, if the compositions of the present inventionare utilized as a mouthwash a much larger amount or a longer duration ofthe use of the composition should be employed as compared to a paintingof the composition onto the teeth by a dental technician.

In the preferred aspect of the present invention, namely the chewinggum, the examples herein give guidelines to the use of the components ofthe present invention to provide effective plaque inhibition. Similarly,it can be seen that for toothpastes, mints, troches, lozenges, andmouthwashes that the manner of using each formulation is to bedetermined by considering the amount of the composition normallyutilized by the individual and the duration that the composition ispresent in the oral cavity.

The alkyl sulfate salt utilized to moderate the incidence of dentalplaque in the present invention, is commonly used in detergentcompositions. In as much as this component is well-known, no detaileddiscussion of the manufacture of the alkyl sulfate salt is given herein.The amount of the alkyl sulfate salt in the various forms of the presentinvention, is generally within the range of 0.001% to about 15% byweight thereof. In its preferred applications, the alkyl sulfate salt isused at from about 0.005% to about 5%, preferably from about 0.01% toabout 3% by weight of the composition.

The term alkyl as used above includes those salts having from about 10to about 18 carbon atoms. Preferably the alkyl sulfate salt is basedupon the corresponding even numbered alcohol. Most preferably the alkylsulfate salt is lauryl sulfate.

The zinc compound is utilized to supply a source of zinc ions to theoral cavity. The zinc compound as previously stated, is utilized at alevel of from about 0.001% to about 5%, preferably from about 0.005% toabout 3%, and most preferably from about 0.01% to about 2% by weight.

The foregoing amounts of the zinc compound are sufficient to provide alevel of about 50 parts per million of zinc ion. Preferably, thecomposition is formulated such that greater than 75 parts per millionand most preferably greater than 130 parts per million of the zinc ionis available from the composition.

The zinc compound is not limited to any one source of zinc ions. Forinstance, suitable salts which supply zinc ions include the phosphates,sulfates, chlorides, fluorides, oxides and zinc fatty acids. Ofparticular interest are zinc phenolsulfonate, zinc oxide and the stearicacid salt of zinc. The last mentioned component is particularly usefulin that it also serves a lubricant function which is desirable whenforming tablets such as for the mint or hard candy variation of thepresent invention.

In the present invention, the weight ratio of the alkyl sulfate salt tothe zinc compound should be in the range of from about 1,000:1 to about1:1000, preferably from about 250:1 to about 1:250 and most preferablyfrom about 20:1 to about 1:20.

The di(2-ethylhexyl)sulfosuccinate salt, as used in the presentinvention, is also known in the art as DSS or dioctyl sulfosuccinate.The foregoing terms are used equivalently in the specification andclaims of this application.

The di(2-ethylhexyl)sulfosuccinate salt is conveniently used at a levelfrom about 0.001% to about 15% by weight of the composition. In its morepreferred aspects of the present invention, the composition contains thedi(2-ethylhexyl)sulfosuccinate salt at from about 0.005% to about 5%,preferably from about 0.01% to about 3% by weight.

In the chewing gum aspect of the present invention, the combined levelof the alkyl sulfate salt and the di(2-ethylhexyl)sulfosuccinate salt isat from about 0.001% to about 25%, preferably from about 0.001% to about10% and most preferably from about 0.001% to about 3% by weight of thechewing gum composition. The weight ratio of the alkyl sulfate salt tothe di(2-ethylhexyl)sulfosuccinate salt is preferably from about 250:1to about 1:250, most preferably from about 20:1 to about 1:20.

The butylated hydroxyanisole component of the present invention is oftenused as a preservative or anti-oxidant in food products. However, inthis invention it has been found that in combination with the remainingingredients that the butylated hydroxyanisole (BHA) inhibits and assistsin removing plaque formation in the oral cavity.

The butylated hydroxyanisole is utilized at from about 0.0005% to about10%, preferably at from about 0.001% to about 3% and most preferably atfrom about 0.0015% to about 2% by weight of the composition.

The plaque inhibiting flavors of the present invention are the essentialoils selected from the group consisting of cinnamon oil, peppermint oil,and spearmint oil, as well as mixtures thereof. The use and preparationof the various essential oils which have been found to inhibit plaqueformation in the compositions of the present invention are well knownand widely used in the food industry. In as much as these essential oilshave been widely approved and used, benefits to the present inventionare thus two fold. First, these essential oils may be used to flavor thecompositions, such as the preferred chewing gum aspect of the presentinvention, and second these materials, which are generally regarded assafe, have the ability to inhibit plaque formation.

The first of the essential oils discussed is cinnamon oil. Cinnamon oilconsists largely of two primary ingredients, namely cinnamic aldehyde(also known as cinnamal) and eugenol. Both of the aforementionedcomponents exist naturally in cinnamon oil in varying concentrationsdetermined by the particular source from which the cinnamon oil isderived. Specifically Ceylon Cinnamon Bark contains the cinnamicaldehyde at from about 50% to 90% by weight of the steam distillate ofthe bark. The eugenol content will ordinarily vary in distillate at fromabout 2% to 15% by weight.

In addition to obtaining the bark distillate from the Ceylon cinnamontree, the bark distillate of Saigon cinnamon has a similar composition.The Saigon cinnamon is found in the Saigon district of Vietnam and isreputed to have peculiar odor and flavor to that of all other forms ofcinnamon bark distillate. Other suitable sources of the cinnamon barkdistillate include Chinese cinnamon which grows wild in Southeast Asia.

In addition to using the distillate of the dried inner bark of theshoots of the coppiced trees; the leaves of the Ceylon, Saigon andChinese cinnamon trees may also be used as a source of cinnamon oil.

The leaves of the various cinnamon trees have a reverse content of theeugenol and cinnamic aldehyde. Typically, the eugenol content runs from70% to 98% by weight of the leaf oil, while the cinnamic aldehyde isgenerally from about 1% to 10% by weight of the leaf oil.

Various other components also make up a minor portion of cinnamon barkor cinnamon leaf oil. These components include caryophyllene,beta-phellandrene, p-cymene, 1-alpha-pinene, 1-linalool, furfural,cinnamic alcohol, benzyl benzoate, cinnamyl acetate, benzaldehyde,methyl salicylate, salicyaldehyde, and coumarin.

Cinnamon oil is the preferred plaque inhibiting flavor in the presentinvention. The use of the term cinnamon oil is meant to embrace a memberof the group consisting of cinnamon aldehyde and eugenol as well asmixtures thereof. A particularly interesting method of includingcinnamon aldehyde in the composition of the present invention is foundin U.S. Pat. No. 3,818,107 issued to Yolles, on June 18, 1974, hereinincorporated by reference. The Yolles patent basically states that asustained release of flavor may be obtained by incorporating thecinnamon aldehyde into a polymer backbone. The sustained release isapparently obtained by the hydrolyzing effect of the saliva upon thepolymer backbone which then releases the cinnamon aldehyde to givecontinuous release of the flavor. In the present invention, of course,not only is the continuous flavor achieved but also a sustained releaseof one of the plaque inhibiting ingredients of the present composition.

The next plaque inhibiting flavor to be discussed is spearmint oil.Spearmint oil is obtained by the steam distillation of the floweringtops of Mentha spicata Houds or L. Labiatae. The spearmint oil containsalpha-pinene, alpha-phellandrene, 1-limonene, octyl alcohol,dihydrocarveol, carvone, and in some varieties dipentene cineol. Of theafore-mentioned components the carvone is the active material in theessential oil and will ordinarily be found at a concentration of fromabout 40% to 90% by weight of the spearmint oil.

The last of the plaque inhibiting flavor oils to be discussed ispeppermint. Peppermint oil is derived from plants in the Labiatae familyand in particular from Mentha piperita L. As with the other plaqueinhibiting flavors, peppermint oil is obtained by steam distillation ofthe flowering plant in yields ranging from about 0.3% to 0.7% dependingupon the particular origin of the plant.

The main constituents found in peppermint oil include menthone,isomenthone menthofuran, menthol, neomenthol, isomenthol menthylacetate, and piperitone. Of the foregoing components menthol in its freeor esterified state is the active component and is found in the oil atlevels from about 40% to 70% by weight of which approximately 80% is infree form and 20% as esterified menthol.

Further information on the composition of the plaque inhibiting flavorsof the present invention may be obtained from Fenaroli's Handbook ofFlavor Ingredients, Second Edition, Volumes 1 and 2, 1975; published byCRC Press, Inc., of Cleveland, Ohio. As it was previously noted, thevarious plaque inhibiting flavors may be used in mixtures with oneanother as well as separately to obtain the benefits of the presentinvention. It is also noted that very interesting flavor combinationsarise when using mixtures of the various essential oils.

The plaque inhibiting flavors of the present invention are generallyutilized at a level of about 0.05% to about 10%, preferably from about0.08% to about 5%, and most preferably at about 0.1% to about 3% byweight of the composition. While the discussion given above is concernedprimarily with natural sources of the plaque inhibiting flavor oils, itis to be noted that the benefits may be obtained from essential oilscontaining various synthetic components.

Where the term salt is employed in the present invention the cation maybe any material which is accepted as safe for food or chewing gum uses.Preferably the cations are selected from a group consisting of sodium,potassium, calcium, magnesium, ammonium, and substituted ammonium andmixtures thereof. The sodium salt is most preferred in the presentinvention both from a cost and a solubility standpoint followed by thecalcium and magnesium salts. Where additional germicidal effect isdesired the ammonium or substituted ammonium salts are particularlyvaluable.

The present invention is particularly concerned with the use of chewinggums as a means for delivering anti-plaque compositions. First, chewinggums are ordinarily used such that prolonged contact with the surface ofthe teeth and gums is obtained. Secondly, the mastication or chewing ofthe gum aids in cleaning or hindering the ability of plaque to tightlyadhere to the teeth. In chewing gums, a gum base is a necessarycomponent.

All manner of natural or synthetic gum bases are to be considered asincluded within the scope of the present invention. Examples of suitablegum bases include chicle, gutta percha, jelutong, balata, namaqulandrubber, almeidana gum, abba rubber, gutta siak, gutta cotie, gutta kay,gutta hangkang, gutta jangkar, gutta sundik, gutta soh, gutta susu,gutta penang, and yellow gutta. Further examples of gum bases includerosins, such as cumarone resin, pontianak resin, copal gum, kauri gum,dammar gum, sweet bay gum, spruce gum, and balsams. Moreover, suitablegum bases include crown gum, nispero, rosidinha, pendare, perillo, nigergutta, and tuno.

Additional chewing gum base materials include elastimers such aspolyisobutylene, polyisosprene, isobutyleneisoprene copolymers andcopolymers of butadiene and styrene, hydrogenated or partiallyhydrogenated vegetable oils such as soy bean, cotton seed, corn, peanut,and palm or animal fats such as tallow and lard. In addition paraffin,beeswax, petroleum wax, polyethylenes, and polyvinylacetates may beemployed. Further descriptions of suitable chewing gum bases are foundin U.S. Pat. No. 2,366,589 issued to Borglin Jan. 2, 1945; U.S. Pat. No.3,821,417, issued to Westall, et al on June 28, 1974; U.S. Pat. No.4,041,179 issued to Stubits et al on Aug. 9, 1977; and U.S. Pat. No.3,984,574 issued to Comollo on Oct. 5, 1976; all of which are hereinincorporated by reference.

The amount of the gum base utilized in the chewing gum aspect of thepresent invention is from about 10% to about 95%, preferably from about15% to about 70% by weight of the chewing gum composition.

While no sweetener is required in the present invention, it is desiredthat the product be appetizing to consumers. Thus, any form of naturalor synthetic sweetener may be included in the present invention. It ispreferred, however, that sucrose, fructose, and glucose content of thecompositions be restricted or eliminated due to the fact that thesematerials provide "food" from which plaque may be formed. Artificialsweeteners such as saccharin, cyclamates, and dihydrochalcones may beincluded at conventional amounts in the compositions of the presentinvention.

A preferred source of sweetening agents for the present invention aremembers selected from the group consisting of xylitol, sorbitol, andmannitol as well as mixtures thereof. The foregoing polyol sugars aregenerally utilized at from about 5% to about 80%, preferably from about10% to about 70% by weight of the composition. The particularlypreferred polyol sugar is xylitol which is reported to haveanti-cariogenic benefits. The use of xylitol in various products such aschewing gums is reported in U.S. Pat. No. 3,296,079 to Griffin, issuedJan. 3, 1967; U.S. Pat. No. 3,655,866, issued to Bilotti on Apr. 11,1972; U.S. Pat. No. 3,914,434 issued to Bohni on Oct. 21, 1975; U.S.Pat. No. 4,000,320 issued to Klose, et al on Dec. 28, 1976 and U.S. Pat.No. 3,899,593 issued to Hammond, et al on Aug. 12, 1975, all of whichare herein incorporated by reference.

A component which may be included in the present invention is analkaline buffer which serves to raise or maintain the pH in the oralcavity. The term alkaline buffer is not meant to imply that the pH inthe oral cavity must be within the alkaline range but rather that it ispreferred that the pH of the oral cavity be in the alkaline range. Infact, the buffering capacity should be such that the pH of the oralcavity is maintained at from about 5.5 to about 10, most preferably fromabout 6 to about 9. Any alkaline buffer or combinations of alkalinebuffers which provide the desired effect may be used. Prominently noted,is the use of bicarbonates particularly sodium bicarbonate to providethe desired pH effect. Other buffers which may be used includecarbonates, sesquicarbonates, citrates, and polyphosphates includingpyrophosphates, orthophosphates, tripolyphosphates, andhexametaphosphate.

The amount of buffer which is required will, of course, depend upon theacidic nature of the composition in which it is being used. It isgenerally found that employing the buffer at from about 1% to about 30%by weight of the composition ensures that the desired pH range in theoral cavity will be met. Preferably the amount of the alkaline bufferemployed is from about 2% to about 20% by weight of the composition.

Another component which is desirably used in the present invention is adental abrasive. Dental abrasives are particularly valuable in chewinggums due to the polishing action which occurs during mastication. Theterm dental abrasive includes all manner and form of such materialswhich are normally used in toothpaste, chewing gums, and the like.Specifically dicalcium diphosphate dihydrate is the preferred dentalabrasive of the present invention. This particular material also servesto function as an alkaline buffer as described above. The use ofdicalcium phosphate and its dihydrate powder are described in U.S. Pat.Nos. 3,011,949 and 3,655,866, issued respectively Dec. 5, 1961 and Apr.11, 1972 to Bilotti, both of which are herein incorporated by reference.

Further dental abrasives which may be utilized in the present inventioninclude calcium carbonate, sodium metaphosphate, aluminum hydroxide,magnesium carbonate, calcium sulphate, silicas including aerogels andxerogels, and tricalcium phosphate. Expanded disclosures of dentalabrasives suitable for use in the present invention are found in U.S.Pat. No. 2,744,049, issued May 1, 1956 to Salzmann, et al, hereinincorporated by reference. The amount of the dental abrasive employed inthe present invention is generally within the range of from about 1% to30%, preferably from about 1.5% to about 20% by weight.

Yet another desirable ingredient in the composition of the presentinvention is the use of glycerine. In the chewing gum aspect of thepresent invention glycerine serves to soften and maintain thechewability of the chewing gum for prolonged periods. The glycerine alsoadds to the sweetness of the composition. The glycerine is ordinarilyadded at levels of from about 0.01% to about 10%, preferably at fromabout 0.2% to about 5% by weight of the composition.

The present invention includes as optional components water or amonohydric alcohol at from about 2% to about 99%, preferably at fromabout 5% to about 70%, and most preferably from about 10% to about 50%by weight of the composition. It is of course recognized that it isparticularly valuable to use mixtures of water and the monohydricalcohol generally within the weight ratio of from about 20:1 to about1:20, preferably from about 10:1 to about 1:10.

The preferred monohydric alcohols are methanol, ethanol, or isopropanolalthough other monohydric alcohols generally including those having upto 18 carbon atoms may be utilized in the present invention. Thepreferred monohydric alcohol is ethanol. It should be recognized thatwhere the product will be ingested that only ethanol should be used.

In vitro testing to determine the effectiveness of the compositions ofthe present invention is conducted in accordance with the acceptedpractices of determining plaque formation. For some of the generalaspects of in vitro testing not discussed below, see "An In Vitro Methodfor Assessing the Plaque Forming Ability of Oral Bacteria," authored byMcCabe et al reported in the ARCHIVES OF ORAL BIOLOGY, Volume 12, pages1653-1656, 1967; and Effect of Microbial Interactions on In Vitro PlaqueFormation by Streptococcus Mutans, by Miller et al reported in theJOURNAL OF DENTAL RESEARCH, March-April 1974, Volume 53, No. 2, pages427-434, both of which are herein incorporated by reference.

The streptococcus mutans used in the experiment was strain 6715, in athree percent (3%) trypticase-soy broth, plus five percent (5%) sucrose.The streptococcus mutans was innoculated into ten (10) milliliters ofsterile broth in a 20×150 mm test tube. Sterile twenty (20) gaugenichrome steel wires, 150 mm long and mounted in No. 2 rubber stoppers,were suspended in the media and incubated for twenty-four (24) hours at37 degrees Celsius. For five (5) consecutive days, the wires weretransferred into freshly reinoculated tubes of sterile media. They werethen transferred through uninnoculated media for five (5) more days. Ineach instance, the wires protruded 37-38 mm below the surface of themedium. At the end of the ten (10) day period, the portion of the wirecontaining the bacterial (plaque) deposit is cut off and placed in apreweighed aluminum pan and dried to a constant weight at 70 degreesCelsius. The dry weight of the plaque is then established by burning offthe plaque deposit in an open flame and reweighing the clean, dry wire.Blank samples of the wire were found not to lose any weight due to theopen flame treatment.

To determine the extent of plaque growth in the presence of thecompositions of the present invention, the foregoing procedure wasfollowed with the exception of the introduction of the variouscomponents of the invention at stated levels. Inactive components, suchas gum base, were not included in each test conducted, due to thedifficulty in handling the test medium solutions. That is, where gumbase is present in the test tube, it is difficult to avoid having someof the gum base adhere to the nichrome wire, thus giving false readingsin the determination of the plaque. The gum bases and other inactivecomponents of the present invention were, however, separately determinedto have minimal effect on plaque growth.

In vivo testing is conducted with human volunteers, using a fullyconstituted product, containing the active plaque inhibiting portion ofthe composition and the inert ingredients. In particular, for thetesting of the chewing gums, a group of twenty (20) volunteers isdivided in random fashion into two (2) groups of ten (10) each. Duringthe first week, one group will chew a controlled gum which is availableon the market, while the second group uses a gum in accordance with thepresent invention. In the second week, regular oral hygiene will befollowed by all subjects in the test. This is to ensure that allvolunteers who are known to readily form plaque will not developgingivitis or any other oral condition, which would affect their healthor the test scores. During the third week, the groups are switched, suchthat the group which previously used the controlled gum will now use thegum made in accordance with the present invention and vice versa.

To demonstrate the effectiveness of the present invention, only alimited amount of chewing gum and chewing time by the subjects isallowed. Further, to demonstrate the effectiveness of the compositionsof the present invention, the testing is conducted such that thesubjects only chew the gum on one side of the mouth during the entiretest. During the test period, the volunteers chew their assigned gum,once in the morning and once in the late afternoon for ten (10) minuteson the right side of the mouth only, under supervision, to ensure thatthe instructions are followed fully. An additional stick of gum is givento each volunteer to chew for ten (10) minutes before going to bed. Thistest is also conducted such that the gum is chewed only on the rightside of the mouth. On the last day of the test period, intra-oralphotographic records of the unstained anterior areas of the mouth aremade. Any gingivitis and dental plaque will be estimated and recorded,according to accepted scientific principles.

To further ensure that the compositions of the present invention areeffective even in the absence of mastication, that is, a high degree ofchewing which alone is known to have some cleaning benefits to theteeth, additional in vitro testing is conducted. In this test, freshlyextracted human teeth were treated three (3) times daily with a freshhuman saliva solution. The teeth received three (3) ten minutetreatments at zero, three and six hour intervals each day, followed byincubation overnight. The tests were variously conducted for one or twodays to determine the initial buildup of plaque in the control and testsolutions. As described earlier the compositions of the presentinvention omitted inert ingredients which were not essential. The amountof plaque buildup on the teeth is determined by the difference in theoptical density of the freshly extracted teeth and the teeth followingthe period of treatment in the saliva with and without the compositionsof the invention present. In general, as noted in the examples, theforegoing series of three (3) tests, indicates a high degree ofeffectiveness of the compositions of the present invention over thecontrol.

EXAMPLE I

A plaque inhibiting gum is prepared according to the present inventionby mixing the following components and pressing the mixture into 3 gramsticks:

    ______________________________________                                        gum base - Paloja L. A. Dreyfuss                                                                        25%                                                 xylitol                   10%                                                 sodium bicarbonate        2%                                                  sorbitol                  33%                                                 Sorbo (70% sorbitol in H2O)                                                                             15%                                                 dicalcium phosphate dihydrate                                                                           5%                                                  mannitol                  5%                                                  glycerine                 0.5%                                                cinnamon oil              0.8%                                                sodium lauryl sulfate     0.8%                                                butylated hydroxyanisole  0.02%                                               zinc oxide                0.8%                                                sodium di(2-ethylhexyl)sulfosuccinate                                                                   0.8%                                                balance coloring          q.s.                                                ______________________________________                                    

The chewing gum when tested as previously described is found effectivein removing plaque from the surface of the teeth and in inhibiting thegrowth of new plaque. The foregoing example may be modified bysubstituting a peppermint or spearmint flavor with similar results.

In use it is suggested that the chewing gum be masticated as singlesticks at least twice a day for a period of ten minutes each time formaximum effectiveness.

EXAMPLE II

Plaque inhibiting mints in hard form weighing 5 grams are preparedcontaining the following ingredients:

    ______________________________________                                        xylitol                   10%                                                 sodium bicarbonate        2%                                                  sorbitol                  65%                                                 Sorbo (70% sorbitol in H2O)                                                                             15%                                                 mannitol                  4%                                                  glycerine                 0.5%                                                cinnamon oil              0.8%                                                sodium lauryl sulfate     0.8%                                                butylated hydroxyanisole  0.02%                                               zinc oxide                0.8%                                                sodium di(2-ethylhexyl)sulfosuccinate                                                                   0.8%                                                balance coloring          q.s.                                                ______________________________________                                    

The plaque inhibiting mint when used as previously described is found tobe effective in inhibiting plaque formation on the surface of the teeth.The mint form of the present invention is preferably used after eachmeal by sucking on the mint for a period of five minutes.

EXAMPLE III

A plaque inhibiting mouthwash is prepared by combining a mixturecontaining:

    ______________________________________                                        water                     85%                                                 ethanol                   8%                                                  sodium bicarbonate        2%                                                  cinnamon oil              0.8%                                                sodium lauryl sulfate     0.8%                                                butylated hydroxyanisole  0.02%                                               zinc oxide                0.8%                                                sodium di(2-ethylhexyl)sulfosuccinate                                                                   0.8%                                                balance coloring          q.s.                                                ______________________________________                                    

The mouthwash is tested as previously described and found to be plaqueinhibiting. Suggested usage for the mouthwash, involves swishing 50 mlof the product in the mouth after each meal for a period of fiveminutes.

What is claimed is:
 1. A chewing gum containing:(a) from about 0.001% toabout 15% by weight of an alkyl sulfate salt; (b) from about 0.001% toabout 15% by weight of a di(2-ethylhexyl)sulfosuccinate salt (c) fromabout 0.0005% to about 10% by weight of butylated hydroxyanisole; (d)from about 0.001% to about 5% by weight of a zinc compound; and, (e)from about 0.05% to about 10% by weight of a plaque inhibiting flavorselected from the group consisting of cinnamon oil, peppermint oil, andspearmint oil and mixtures thereof; and, (f) from about 10% to about 95%by weight of a gum base.
 2. The chewing gum of claim 1 containing:(a)from about 0.005% to about 5% by weight of the alkyl sulfate salt; (b)from about 0.005% to about 5% by weight of adi(2-ethylhexyl)sulfosuccinate salt; and, (c) from about 0.001% to about3% by weight of butylated hydroxyanisole; (d) from bout 0.005% to about3% by weight of a zinc compound; and, (e) from about 0.08% to about 5%by weight of a plaque inhibiting flavor selected from the groupconsisting of cinnamon oil, peppermint oil, and spearmint oil andmixtures thereof.
 3. The chewing gum of claim 2 containing:(a) fromabout 0.01% to about 3% by weight of the alkyl sulfate salt; (b) fromabout 0.01% to about 3% by weight of a di(2-ethylhexyl) sulfosuccinatesalt; (c) from about 0.0015% to 2% by weight of butylatedhydroxyanisole; (d) from about 0.01% to 2% by weight of a zinc compound;and, (e) from about 0.1% to 3% by weight of a plaque inhibiting flavorselected from the group consisting of cinnamon oil, peppermint oil andspearmint oil and mixtures thereof.
 4. The chewing gum of claim 3wherein the cation of the alkyl sulfate salt is selected from the groupconsisting of sodium, potassium, calcium, magnesium, ammonium, andsubstituted ammonium and mixtures thereof.
 5. The chewing gum of claim 4wherein the cation of the di(2-ethylhexyl)sulfosuccinate salt isselected from the group consisting of sodium, potassium, calcium,magnesium, ammonium, and substituted ammonium and mixtures thereof. 6.The chewing gum of claim 4 containing from about 0.01% to about 10% byweight of glycerine.
 7. The chewing gum of claim 6 containing from about5% to about 80% by weight of a member selected from the group consistingof xylitol, sorbitol, and mannitol and mixtures thereof.
 8. The chewinggum of claim 7 containing from about 1% to about 30% by weight of amember selected from the group consisting of dental abrasives andalkaline buffers and mixtures thereof.
 9. The chewing gum of claim 8wherein the plaque inhibiting flavor is cinnamon oil.
 10. The chewinggum of claim 9 wherein the alkyl sulfate salt is lauryl sulfate.
 11. Thechewing gum of claim 10 wherein the cation of thedi(2-ethylhexyl)sulfosuccinate salt is sodium.
 12. The chewing gum ofclaim 11 wherein the zinc compound is selected from the group consistingof zinc phosphates, zinc sulfates, zinc chlorides, zinc fluorides, zincoxides, and zinc fatty acids.
 13. The chewing gum of claim 12 whereinthe zinc compound is selected from the group consisting of zincphenolsulfonate, zinc oxide and the stearic acid salt of zinc.
 14. Thechewing gum of claim 13 wherein the weight ratio of the alkyl sulfatesalt to the zinc compound is about 20:1 to 1:20.